Commission Implementing Regulation (EU) 2024/1611 of 6 June 2024 authorising the placing on the market of isomaltulose powder as a novel food and amending Implementing Regulation (EU) 2017/2470

• CELEX: Implementing Regulation (EU) 2024/1611
• Articles: 3

Article 1

1.   Isomaltulose powder is authorised to be placed on the market within the Union.

Isomaltulose powder shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

2.   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the following entry is inserted:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

‘ Isomaltulose powder

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be “isomaltulose powder”.

2.

The designation of the novel food on the labelling shall be accompanied by indication that the “Isomaltulose is a source of glucose and fructose”.’

All foods, excluding foods and drinks intended specifically for infants and young children

(2)

in Table 2 (Specifications), the following entry is inserted:

Authorised Novel Food

Specification

‘ Isomaltulose powder

Description/Definition:

The novel food is isomaltulose powder produced from sucrose by a microbiological process using Serratia plymuthica . The dry matter content is a mixture of mono-and disaccharides, mainly composed of isomaltulose (≥ 75 %) and trehalulose (≤ 13 %) and, to a minor extent, glucose, fructose, sucrose and oligosaccharides (traces).

Characteristics/composition:

Isomaltulose (% DM): ≥ 75

Trehalulose (% DM): ≤ 13

Glucose (% DM): ≤ 3

Fructose (% DM): ≤ 4

Sucrose (% DM): ≤ 5

Moisture (%): ≤ 7

Ash (%): ≤ 0,05

Protein (%): < 0,1

Chemical identity of isomaltulose:

Chemical (IUPAC) name: α-D-glucopyranosyl-(1 → 6)-D-fructofuranose

Common name: Isomaltulose

CAS number: 13718–94-0

Molecular formula: C 12 H 22 O 11

Molecular weight: 342,30 g/mol

Chemical identity of trehalulose:

Chemical (IUPAC) name: α-D-glucopyranosyl-(1 → 1)-D-fructofuranose

Common name: Trehalulose

CAS number: 51411–23-5

Molecular formula: C 12 H 22 O 11

Molecular weight: 342,30 g/mol

Heavy metals:

Lead (mg/kg): ≤ 0,1

Microbiological criteria:

Total aerobic microbial count: < 100 CFU/g

Total yeast and mould count: < 100 CFU/g

E. coli : < 10 CFU/g

Enterobacteriaceae: < 100 CFU/g

Salmonella : not detected in 25 g

CFU: colony forming units

DM: dry matter’